MERIT Act

The MERIT Act amends Medicare's coverage rules to require individual drug reviews for research purposes. It changes how Medicare determines if a drug is "reasonable and necessary" under Section 1142 research programs, mandating separate evaluations for each drug instead of class-based decisions. This directly affects Medicare beneficiaries and drug manufacturers participating in research under Section 1142. The key provision specifies that coverage determinations must apply to each specific drug or biological involved in the research, not to groups of similar drugs. This policy change alters the Medicare national coverage determination process for research-related treatments.